PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Zenition 70, Model #718133

Is my product affected?

Zenition 70, Model #718133

• UPC 459801238191
• UPC 459801238231

Check against the official notice below — it lists the full affected range.

What happened

Philips Medical Systems Nederland B.V. has recalled the Zenition 70 wireless foot switch (Model #718133) due to a firmware issue that can cause the device to suddenly stop responding. If the wireless foot switch fails and neither the hand switch nor a wired foot switch is being used, there could be a delay or interruption during medical procedures. The affected wireless foot switches have lot codes 459801238191 and 459801238231, with approximately 95 units distributed in the United States and 284 units distributed internationally across multiple countries.

The recall affects units distributed to Arizona, California, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington, and West Virginia, as well as worldwide locations. The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

Details from the source

Reason for recall: Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system. Distribution: Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution. Quantity: 95 US; 284 ROW Lot/code info: Wireless Foot switch 3P : 459801238191 Wireless Foot switch 3P: 459801238231

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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